MAUDE Adverse Event Report: ARTIVION, INC. ¿ KENNESAW BIOGLUE SYRINGE 5-PACK, 2ML; GLUE,SURGICAL,ARTERIES

Model Number BG3502-5-G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling/ Edema (4577)

Event Date 02/05/2023

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

Event Description

According to initial reports, on (b)(6) 2023, patient experienced fluid leakage and swelling at incision site.Surgeon reopened patient and removed bioglue.Surgeon cleaned around the dura and found dura to be unaffected.The surgeon closed the incision without replacing the plate.Patient has a history of trigeminal neuralgia date of original surgery with the use of bioglue - (b)(6) 2022 for keyhole microvascular decompression.

Manufacturer Narrative

According to initial reports, on 5feb2023, a case of fluid leakage from the incision site where bioglue was used was observed by the surgeon.The patient presented with swelling around the incision line behind the ear.Surgical intervention was required to remove the titanium mesh and bioglue.The incision was closed without replacing the plate.Patient history: trigeminal neuralgia operation: keyhole microvascular decompression date of initial surgery:(b)(6) 2022.This investigation is relegated to bg3502-5-g lot# bg000601.The product will not be returned to the manufacturer for evaluation.The manufacturing records for the bg3502-5-g lot# bg000601 were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review of the available information was performed.Upon review of the attached video, it was noted that there was purulent appearing fluid visible after the initial incision.The surgeon noted that the dura remained intact, so the fluid collection likely represents an inflammatory reaction to a foreign body (bioglue and titanium mesh plate).Although no infection was mentioned by the surgeon, the purulent fluid may have resulted from a skin infection at the original incision site.Miscusi used bioglue in 12 patients who underwent spinal surgery; patient follow-up occurred at 3 months and 1 year.There were no complications in the bioglue group and no local or systemic adverse reactions to bioglue were observed during at 1-year.The authors do state in their experience a single very thin layer of bioglue is sufficient and that the application of larger quantities may create a ¿pooling of glue, potentially leading to serious side effects such as compression of spinal cord and nerve roots¿ (miscusi et al.2014).Miscusi suggests in spinal dural closures bioglue should be applied <1mm thick along the suture lines (miscusi 2011).The ifu lists observed adverse event ¿inflammatory reaction.¿ the amount of bioglue used is unknown; however, if a large amount was utilized it could result in an enhanced or prolonged inflammatory reaction.Based on the information available at the time of this report, we are unable to definitively determine the cause of the events observed.The surgeon does not mention infection, but possible skin infection cannot be ruled out at this time.Inflammatory response related to the use of bioglue and/or the titanium mesh plate cannot be excluded in relation to the reported event.Inflammatory response to bioglue is a known possible complication and adequate precautions and warning are present in the ifu.No action required at this time.Based on the information available at the time of this report, we are unable to definitively determine the cause of the events observed.If information is provided in the future, a supplemental report will be issued.The manufacturing records were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion ¿ formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 2ML
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 16452939
• MDR Text Key: 310348011
• Report Number: 1063481-2023-00005
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/16/2024
• Device Model Number: BG3502-5-G
• Device Lot Number: BG000601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/07/2023
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention